Packaging Mechanic I

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. 

Our Packaging Department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Packaging Mechanic I for 2nd shift. 

The Packaging Mechanic I is responsible for supporting and assisting the Packaging Department in ensuring efficient packaging of goods by performing packaging equipment maintenance including, but not limited to: troubleshooting, repair, upgrade, preventive maintenance (PM), etc. on various types of packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) requirements.

Essential Functions & Responsibilities:

· Responsible for all aspects of Packaging equipment maintenance in accordance with company policies, SOPs, cGMPs and FDA requirements 

· Performs packaging line change overs and startups

· Assists Packaging Operations/Quality Assurance (QA) activity during the running of packaging lines

· Performs routine and complex work related to the troubleshooting, repair, and upgrade of all packaging equipment including but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.

· Responsible for performing PM, repair and continuous improvement of packaging equipment

· Assists in performing root cause analysis on equipment failures to support investigations

· Ensures packaging equipment is operating safely at all times 

REQUIREMENTS:

Minimum education and years of relevant work experience required:

High School diploma or equivalent and minimum 3 years packaging mechanic experience in the pharmaceutical or biotechnology industry. 

Special knowledge or skills needed and/or licenses or certificates required:

· Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes 

· Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs

· Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.

· Hands on experience with repair, maintenance and troubleshooting of pharmaceutical packaging equipment (i.e., fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.)

· Basic PC skills

· Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members 

· Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

· Planning, organization and time management skills including the ability to support and prioritize multiple projects 

· Fluent in English (verbal and written)

· Ability and willingness to work additional hours as required by business needs  

Special knowledge or skills needed and/or licenses or certificates preferred:

Trade school or certification 

 Hands on electrical/electronic troubleshooting  experience

Physical requirements:

Manufacturing based position

Ability to lift up to 50 lbs

Ability to use Personal Protective Equipment (PPE)

Ability to stand for extended periods